Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Physician-reported clinical outcomes, PFS |
from date of second-line treatment initiation until progression by RECIST1.1 criteria, or death |
From enrolment to follow-up of up to 36 months |
|
| Primary |
Physician-reported clinical outcomes, OS |
the date of second-line treatment initiation until death from any cause(only for patients receiving 2L CT and 2L TKI, separately) |
From enrolment to follow-up of up to 36 months |
|
| Primary |
Time to initiate second line therapy from progression from 1L treatment |
Time to initiate second line therapy from RECIST1.1 defined progression from 1L treatment |
From enrolment to follow-up of up to 36 months |
|
| Primary |
Response rate |
Response rate reported by physician or judged by Recist1.1 after receiving any pattern of therapy |
From enrolment to follow-up of up to 36 months |
|
| Primary |
chemotherapy |
For each line of chemotherapy received but not limited in:Therapy regimen,Therapy duration measured as time from therapy start date to time of therapy end date,Number of cycles received,Reason for cessation of therapy |
From enrolment to follow-up of up to 36 months |
|
| Primary |
immunotherapy |
For each line of immunotherapy received but not limited in:Therapy regimen,Therapy duration measured as time from therapy start date to time of therapy end date,Number of cycles received,Reason for cessation of therapy |
From enrolment to follow-up of up to 36 months |
|
| Primary |
targeted therapy |
For each line of targeted therapy received but not limited in:Therapy regimen,Therapy duration measured as time from therapy start date to time of therapy end date,Number of cycles received,Reason for cessation of therapy |
From enrolment to follow-up of up to 36 months |
|
| Primary |
local therapy |
For each line of local therapy received but not limited in:Therapy regimen,Therapy duration measured as time from therapy start date to time of therapy end date,Number of cycles received,Reason for cessation of therapy |
From enrolment to follow-up of up to 36 months |
|
| Primary |
palliative/supportive care |
Any palliative/supportive care received |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Molecular testing sample type |
To estimate parameters in the target population associated with molecular testing patterns, including molecular testing sample type |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Molecular test outcome |
To estimate parameters in the target population associated with molecular testing patterns, including molecular test outcome |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
changes in testing rate over time |
To estimate parameters associated with molecular testing patterns, including changes in testing rate over time |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Molecular testing rate |
Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Time from progression date to molecular testing |
Time from the RECIST defined progression date to molecular testing |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Molecular testing method of biopsy |
To estimate parameters in the target population associated with molecular testing patterns, including molecular testing method of biopsy |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Molecular testing turnaround time |
To estimate parameters in the target population associated with molecular testing patterns, including molecular testing turnaround time |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Molecular test type |
To estimate parameters in the target population associated with molecular testing patterns, including molecular test type |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
reason for molecular testing |
To estimate parameters in the target population associated with molecular testing patterns, including reason for molecular testing |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Molecular testing laboratory type |
To estimate parameters in the target population associated with molecular testing patterns, including molecular testing laboratory type |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
reason for not performing a molecular test |
To estimate parameters in the target population associated with molecular testing patterns including reason for not performing a molecular test |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
mutation status |
To estimate parameters in the target population associated with molecular testing patterns including molecular testing result of mutation status |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
mutation type |
To estimate parameters in the target population associated with molecular testing patterns, including molecular result of mutation type |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
histologic/phenotypic transformation |
To estimate parameters in the target population associated with molecular testing patterns, including histologic/phenotypic transformation |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Overall CNS metastases rate |
Overall CNS metastases rate, defined as the number of patients developing CNS metastases divided by the number of evaluable patients (From start of 2L therapy) |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Brain metastases rate |
Brain metastases rate, defined as the number of patients developing brain metastases divided by the number of evaluable patients |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Leptomeningeal metastases rate |
Leptomeningeal metastases rate, defined as the number of patients developing leptomeningeal metastases divided by the number of evaluable patients |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Type of treatments for CNS metastases |
Treatments for CNS metastases, including type of treatment |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Date of treatments for CNS metastases |
Treatments for CNS metastases, including dates of treatment |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Change in score from baseline for each QoL domain measured at each subsequent site visit |
To assess patient-reported HRQoL using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13) |
From enrolment to follow-up of up to 36 months |
|
| Secondary |
Change in score from baseline for overall QoL measured at each subsequent site visit |
To assess patient-reported HRQoL using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13) |
From enrolment to follow-up of up to 36 months |
|
